Status:
COMPLETED
Study to Evaluate Reactogenicity and Immunogenicity of Revaccination With Adjuvanted Influenza Vaccine in Elderly Adults
Lead Sponsor:
GlaxoSmithKline
Conditions:
Influenza
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
Since influenza vaccines are normally administered every year because of the frequent change in their antigenic composition, the safety and immunogenicity profiles of the adjuvanted influenza vaccine ...
Eligibility Criteria
Inclusion
- The subjects must be healthy adults ages 18-40 years or \>/= 65 years previously vaccinated with either Fluarix or the adjuvanted vaccine.
Exclusion
- Subjects will be excluded if they take/have taken chronically high doses of immunosuppressants or other immune modifying drugs within six months before vaccination, or immunoglobulins or blood products within three months before vaccination, or any investigational product within 30 days before vaccination
- Have a history of influenza infection since previous vaccination
- Women who are pregnant
- Subjects who have an acute or chronic clinically significant disease or an immunosuppressive/deficient condition, or have contra-indications to influenza vaccination
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00386698
Start Date
October 1 2006
End Date
December 1 2006
Last Update
October 7 2016
Active Locations (1)
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1
GSK Investigational Site
Ghent, Belgium, 9000